Conventionally, a surgeon may execute delicate suturing operations with tiny, fine needles to reconnect severed body lumens. However, installation of sutures with a needle to connect severed tissues can be a difficult and technique-sensitive task. Many factors can make the task difficult, including small amounts of tissue to work with (e.g., at the urethral stump and at a bladder neck), and proximity to sensitive tissues such as ureters at a bladder and a proximal nerve bundle and sphincter at a urethral stump. These factors result in complicated and delicate suturing procedures that, if not performed properly, can result in complications such as leakage, difficulty in healing or failure to heal, or specific conditions such as incontinence or impotence.
To reduce the risks involved in conventional suturing procedures, anastomosis devices have been developed that include a drainage feature and tissue approximating structure that allow for reconnection of tissues without using traditional sutures. Commercially, a representative anastomosis device can include those available from American Medical Systems of Minnetonka, Minn., which are further described in United States Patent Publications 2004/0087995, 2005/0070938, 2005/01314312006/0200178, 2006/0264985, 2006/0276811 and 2007/0219584, all of which are incorporated herein by reference in their entireties. These anastomosis devices advantageously use tissue approximating structures to reconnect severed tissues during anastomosis procedures. The anastomosis device reduces the risks during the surgical procedure and also provides a significant reduction in the amount of time required to perform certain anastomosis procedures. Because the anastomosis device will typically be surgically positioned within the patient for a significant period of time (e.g., while the healing process takes place), there is a need for the device to be sufficiently strong and flexible to accommodate the various stresses to which the device may be subjected while positioned within the patient.
Anastomosis procedures are generally performed to connect or reconnect certain body tissues, typically in the form of tubular structures as part of a surgical procedure. Typically, these tissues define a body lumen such as, for example, a blood vessel, intestinal, digestive or urinary tissue that has been severed and requires reconnection as part of a successful treatment.
One representative anastomosis procedure can include a radical prostatectomy procedure in which, a surgeon removes all or most of a patient's prostate. The procedure generally leaves a severed urethral stump and a severed bladder neck, which must be reconnected so as to restore proper urinary functions. Through the use of a combination of retention features including an inflation balloon and a plurality of tissue approximating structures, the urethral stump and bladder neck can be aligned and retained in contact throughout a healing period for the tissue. While the urethral stump and bladder neck are forcibly held in approximation during healing, the anastomosis device provides a drainage lumen allowing bodily fluids and other materials to pass through the drainage lumen during the healing period.
While the aforementioned anastomosis device effectively reconnects tissue during certain surgical procedures, it would be advantageous to provide an anastomosis device providing treatment options for additional anastomosis procedures and to improve upon present designs and methods to enhance the functionality, reliability and safety associated with use of anastomosis devices.